A Study in Participants With Obesity or Overweight With at Least One Weight-related Comorbidity

Phase 2

Active, not recruiting

• Conditions: Obesity or Overweight
• Interventions: Drug: AZD6234; Drug: Placebo comparator

• Registration Number: NCT06595238
• Lead Sponsor: AstraZeneca

Brief Summary

A Phase IIb Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of AZD6234 compared with placebo, given once a week as subcutaneous injection for 36 weeks, in male and female participants of at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and at least one weight-related comorbidity

Detailed Description

The study will comprise of:

A screening period of maximum 28 days

A treatment period of 36 weeks

A follow up period after last dose of study drug

This study will consist of 4 cohorts. Approximately 231 eligible participants will be randomized to AZD6234 or placebo

Study Timeline

• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-11
• Study First Posted: 2024-09-19
• Study Start: 2024-10-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-08-15
• Study Completion: 2025-12-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 262

Inclusion Criteria

• Adults ≥ 18 years of age
• BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27kg/m2 and have a current diagnosis of at least 1 weight-related comorbidities (treated or untreated)
• A stable body weight for 3 months prior to Screening (±5% body weight change)

Exclusion Criteria

• Have obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome
• Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening
• Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier)
• History of type 1 diabetes mellitus or T2DM

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	AZD6234	Dose 1
Arm 2	AZD6234	Dose 2
Arm 3	AZD6234	Dose 3
Arm 4	Placebo comparator	Placebo - Dose matched with each Experimental arm

Primary Outcome Measures

Name	Time	Method
Percent change in body weight from baseline to week 26	26 weeks	To determine whether AZD6234 is superior to placebo for weight loss
Weight loss ≥ 5% from baseline weight to week 26	26 weeks	To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline

Secondary Outcome Measures

Name	Time	Method
Weight loss ≥ 5% from baseline to week 36	36 weeks	To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 5% from baseline
Weight loss ≥ 10% from baseline to week 36	36 weeks	To determine whether AZD6234 is superior to placebo in participants with weight loss ≥ 10% from baseline
Percent change in body weight from baseline to week 36	36 weeks	To determine whether AZD6234 is superior to placebo for weight loss
Absolute change in body weight (kg) from baseline to week 26 and week 36	week 26 and week 36	To determine whether AZD6234 is superior to placebo for absolute weight loss
AZD6234 plasma concentrations	Week 43	To characterise the PK of AZD6234

Trial Locations

Locations (1)

Research Site; 🇬🇧 Rotherham, United Kingdom